Relapsed/Refractory Multiple MyelomaNCT06659770
A Real-World Observational Study: Zevorcabtagene Autoleucel Injection in Patients with Relapsed/Refractory Multiple Myeloma
An observational study of Relapsed/Refractory Multiple Myeloma, run by CARsgen Therapeutics Co., Ltd..
Trial summary
This study is a single-arm, open-label, multicenter, post-marketing, Phase IV, prospective, observational clinical trial to evaluate the efficacy and safety of the post-marketing product zevor-cel as treatment for subjects with R/R MM in the real world. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed/Refractory Multiple Myeloma
- What is being tested?
- Zevorcabtagene Autoleucel
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study was conducted in a medical institution that has been commercially evaluated and certified. Before carrying out the corresponding procedures for the study, the informed consent signed by the subjects themselves must be obtained, and for patients who do not have full civil capacity, the informed consent of their guardians must be obtained.
Who may be able to join
- Age ≥ 18 years;
- Subjects with refractory/relapsed multiple myeloma who meet product indication criteria and have received commercialized zevor-cel infusion.
- Voluntary participation in this study and willingness to sign the informed consent form, for subjects incapable to provide consent, informed consent must be obtained from their legally acceptable guardians.
Who cannot join
- 1. There were no specific exclusion criteria for this study。
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This study is a single-arm, open-label, multicenter, post-marketing, Phase IV, prospective, observational clinical trial to evaluate the efficacy and safety of the post-marketing product zevor-cel as treatment for subjects with R/R MM in the real world.
Read the detailed description
Primary study endpoints:
Overall Survival Rate (OS Rate) at 24 months after infusion：Survival rate from the start of cell infusion to 24 months after infusion.
Secondary study endpoints:
Incidence and Severity of Treatment-Related Adverse Events (TEAEs) for zevor-cel Incidence and severity of adverse events (AEs) related to study treatment Incidence of serious adverse events (SAEs) related to study treatment
Other efficacy endpoints of zevor-cel:
Overall response rate (ORR)：Proportion of subjects with a partial response (PR) or above.
Complete response or stringent complete response rate (CR/sCR) ：The proportion of subjects with the best response of CR/sCR.
Duration of Response (DOR)：The time from first response to disease progression or death caused by any reasons in subjects with the best response of PR and above.
Progression Free Survival (PFS) Overall survival (OS)： The time from the start of cell infusion to death due to any cause.
- Conditions
- Relapsed/Refractory Multiple Myeloma
- Being tested
- Zevorcabtagene Autoleucel
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zevorcabtagene AutoleucelDrug
Zevorcabtagene Autoleucel is a novel fully human BCMA-targeting CAR-T therapy
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate long-term survival benefits of zevor-cel in subjects with R/R MM
Statistical analysis of OS will be performed, survival curves of OS will be plotted, and 1-year and 2-year survival rates will be calculated. The median, 25% quantile, and 75% quantile of OS will be calculated with their 95% confidence intervals.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study startOct 2024 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CARsgen Therapeutics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06659770
- Sponsor's protocol ID
- CT053-MM-05
- Status last verified
- Jul 2024
- First submitted
- 24 Oct 2024
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-World Observational Study: Zevorcabtagene Autoleucel Injection in Patients with Relapsed/Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT06659770
- Acronym / sponsor ID
- CT053-MM-05
- Conditions
- Relapsed/Refractory Multiple Myeloma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- CARsgen Therapeutics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2024 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 26 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a single-arm, open-label, multicenter, post-marketing, Phase IV, prospective, observational clinical trial to evaluate the efficacy and safety of the post-marketing product zevor-cel as treatment for subjects with R/R MM in the real world.
Detailed description
Primary study endpoints:
Overall Survival Rate (OS Rate) at 24 months after infusion：Survival rate from the start of cell infusion to 24 months after infusion.
Secondary study endpoints:
Incidence and Severity of Treatment-Related Adverse Events (TEAEs) for zevor-cel Incidence and severity of adverse events (AEs) related to study treatment Incidence of serious adverse events (SAEs) related to study treatment
Other efficacy endpoints of zevor-cel:
Overall response rate (ORR)：Proportion of subjects with a partial response (PR) or above.
Complete response or stringent complete response rate (CR/sCR) ：The proportion of subjects with the best response of CR/sCR.
Duration of Response (DOR)：The time from first response to disease progression or death caused by any reasons in subjects with the best response of PR and above.
Progression Free Survival (PFS) Overall survival (OS)： The time from the start of cell infusion to death due to any cause.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study was conducted in a medical institution that has been commercially evaluated and certified. Before carrying out the corresponding procedures for the study, the informed consent signed by the subjects themselves must be obtained, and for patients who do not have full civil capacity, the informed consent of their guardians must be obtained.
Key inclusion criteria (3 listed)
- Age ≥ 18 years;
- Subjects with refractory/relapsed multiple myeloma who meet product indication criteria and have received commercialized zevor-cel infusion.
- Voluntary participation in this study and willingness to sign the informed consent form, for subjects incapable to provide consent, informed consent must be obtained from their legally acceptable guardians.
Key exclusion criteria (1 listed)
- 1. There were no specific exclusion criteria for this study。
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zevorcabtagene AutoleucelZevorcabtagene Autoleucel is a novel fully human BCMA-targeting CAR-T therapy | Drug | – |
Primary outcome
To evaluate long-term survival benefits of zevor-cel in subjects with R/R MM
Time frame: 24 months
Statistical analysis of OS will be performed, survival curves of OS will be plotted, and 1-year and 2-year survival rates will be calculated. The median, 25% quantile, and 75% quantile of OS will be calculated with their 95% confidence intervals.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsed/Refractory Multiple Myeloma, run by CARsgen Therapeutics Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenming Chen (13910107759, 13910107759@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate long-term survival benefits of zevor-cel in subjects with R/R MM (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2024.